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RECRUITING Not applicable ClinicalTrials.gov

Kulindana: Community-friendly Delivery and Monitoring of TPT to Improve Uptake and Reduce TB Transmission

Sponsor: University of Washington • ClinicalTrials.gov ID: NCT07628140

Registry updated: 2026-08-27
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Description

The goal of this clinical trial is to learn if differentiated service delivery (DSD) of TB preventive therapy (TPT) improves uptake and completion of TPT in two populations: household contacts (HHC) of index TB patients and people living with HIV (PWH). The main questions it aims to answer are: * Is community-based and multi-month dispensing of short-course TPT with minimal clinic and laboratory monitoring associated with higher rates of initiation and completion of TPT, compared to standard of care, in both HHC and PWH? * Does community-based and DSD TPT reduce household and community TB transmission? Researchers will compare DSD TPT delivery to standard of care (SoC) to see if DSD TPT delivery has an effect on TPT uptake and completion. Participants will: * Be assessed for TPT eligibility through either DSD TPT service delivery of SoC including differentiated TB screening procedures. * If eligible, receive DSD TPT service delivery or SoC TPT service delivery. * Over 12 weeks receive either DSD or SoC TPT adherence assessment and follow-up. * Have TPT completion assessed at 12 weeks following enrolment. * A subset of participants will be assess for TB incidence at 9 months following enrolment.

Interventions

  • Differentiated service delivery (DSD) of TB preventive therapy (TPT) (Other)
    TPT is normally provided at clinics with monthly visits for refills, but the full course of TPT can also be provided all at once through differentiated service delivery (DSD) of TPT. By doing the Kulindana study, the investigators hope to learn which way of delivering TPT to participants (through usual clinic practice, or all at once) is best for helping participants finish a full course of TPT.

Eligibility criteria

Inclusion Criteria: * Household contacts (HHC) are eligible for enrolment if the participant shares a residential dwelling with an index TB patient and can provide informed consent (or parental consent, with assent if appropriate). * People living with HIV (PWH) are eligible for enrolment if the participant is an adult aged 15 and over, is eligible for TPT according to Kenyan National Guidelines, and can provide informed consent. Exclusion Criteria: * HHC will be excluded if the participant plans on permanently relocating from the area within the next three months, is not willing to receive TPT screening and initiation at home, or is enrolled in any other investigational/interventional HIV or TB study. * PWH will be excluded if the participant plans on permanently relocating from the area within the next three months, has contraindications for TPT according to the Kenyan National Guidelines, or is enrolled in any other investigational/interventional HIV or TB study.

Conditions

Tuberculosis Prevention HIV

Locations

  • Centre for Family Health Research and Development (CEFERD) located at Jaramogi Oginga Odinga Teaching and Referral Hospital — Kisumu, Kenya
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record